Senior Quality Engineer

ACE Partners; Santa Cruz (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

ACE Partners, an early-stage medical device company, seeks a hands-on Senior Quality Engineer to own quality from supplier qualification to final release. The role emphasizes supplier quality, design quality, and operations quality in a fast-paced startup.

The ideal candidate has a Bachelor's in engineering, 5–8+ years in medical devices or regulated fields, deep knowledge of FDA and ISO 13485, and strong CAPA/SPC skills. CQE/CQA or Six Sigma is a plus.

Qualifications

• Bachelor's in engineering or related technical field required.
• 5–8+ years in quality engineering within medical devices or regulated industries.
• Strong knowledge of FDA regulations and ISO 13485.
• Capable of root cause analysis, CAPA, SPC, MSA/gauge R&R, and sampling.
• Startup or early-stage device experience plus CQE/CQA or Six Sigma is a plus.

Responsibilities

• Own supplier quality, including supplier qualification, audits, inspection plans, SCARs and CAPAs.
• Own design quality across R&D with design controls, FMEA, risk management, V&V and transfer.
• Own operations quality: resolve NCRs/MRB issues, support IQ/OQ/PQ and test method validation.
• Maintain quality records and keep processes audit-ready as the company grows.

Skills

Root cause analysis

CAPA

SPC

Gauge R&R

Metrology

Calibration

FDA regulations

ISO 13485

Design controls

Risk management

Education

Bachelor's in engineering or related technical field

Master's degree (plus)

Tools

Six Sigma

FMEA

Job description

Senior Quality Engineer | Early-Stage Structural Heart Device Company

Santa Cruz, CA | Onsite 5 days a week | Full-time

Our client is an early-stage medical device company building next-generation implantable therapies for structural heart disease. They need a hands-on Senior Quality Engineer to own quality across their implants, from first supplier to final release.

What you'll do

• Supplier quality (50%): Qualify and audit suppliers, set inspection and sampling plans, run SCARs and CAPAs, and drive supplier performance
• Design quality (30%): Be Quality's voice on the R&D team across design controls, FMEA and risk management, V&V and design transfer
• Operations quality (20%): Resolve NCRs and MRB issues, support IQ/OQ/PQ and test method validation, and sign off on product release
• Keep quality records and processes audit-ready as the company grows

What you bring

• Bachelor's in engineering or a related technical field (Master's a plus)
• 5 to 8+ years of quality engineering in medical devices or another regulated industry
• Strong working knowledge of FDA regulations and ISO 13485
• Confident with root cause analysis, CAPA, SPC, MSA/gauge R&R and sampling, with a working knowledge of metrology and calibration
• Startup or early-stage device experience is a big plus, as is CQE/CQA or Six Sigma